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Launch of new guidance to make children’s medicines safer and more effective

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The Hague • 13 June 2016

To address the gap in children’s medicines, the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) today release new guidelines for health care professionals prescribing or supplying medicines for children when no authorised product exists. The guidelines are available to all countries and professionals on the two organisations’ web sites.

Paediatricians and health professionals all over the world have long struggled with the lack of authorised and commercially available child-specific medicines. They are often forced to use adult medicines when treating children, for example by crushing tablets or making products from scratch. This approach poses significant risks, increasing the potential for inaccurate dosing and impacting on the quality, safety and efficacy of the medicine.

The new guidance provides advice based on the available evidence, best practices and sound scientific and therapeutic principles. For instance, if a prescribed medicine is not available in an age-appropriate formulation, using a commercially available medicine with a similar therapeutic action, which is available in a more suitable form, may be considered. Examples are provided.

“Children are more susceptible to medication errors and at greater risk of negative consequences from them. Right now in hospitals we still have to compound products for children every day, many times a day, and this guidance — the first international consensus-based approach dealing with this subject — is much needed,” said Dr Régis Vaillancourt, Director of Pharmacy at the Children’s Hospital of Eastern Ontario, Canada, and a contributor to the guidance document.

“We need to ensure these guidelines are made available to all countries, particularly in poorly-resourced ones, where the burden of disease and children’s need for treatments are more acute,” said Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, WHO. “While we wait for the research industry to catch up on children’s medicines, this is the best alternative we have at present.”

“Better access to safe and effective medicines for children is an important part of reducing child mortality; a United Nations Sustainable Development Goal target. This guidance, the result of more than 5 years of work, will improve children’s access to treatment,” said Ms Gugu Mahlangu, chairperson of the expert committee to the guidance and Director General of the Medicines Control Authority of Zimbabwe.


Notes for editors

The document “FIP-WHO technical guidelines: Points to consider in the provision by health care professionals of children-specific preparations that are not available as authorized products” is available here.

About the World Health Organization

The World Health Organization is the directing and coordinating authority on international health within the United Nations’ system. It provides leadership on matters critical to health and engages in partnerships where joint action is needed; sets, promotes and monitors norms and standards; and shapes the health research agenda.

About FIP

The International Pharmaceutical Federation (FIP) is the global federation of national associations of pharmacists and pharmaceutical scientists, and is in official relations with the World Health Organization. Through its 137 member organisations, it represents over three million practitioners and scientists around the world.


Lin-Nam Wang, communications manager


Tel +31 70 302 1987

Last update 5 July 2018

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